Safety and Efficacy Trial Evaluating the Use of SR34006 in the Treatment of Deep Vein Thrombosis (DVT)

Deep Vein Thrombosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00067093
• Other study ID #: EFC3491
• Secondary ID: SR34006
• Status: Completed
• Phase: Phase 3
• First received: August 11, 2003
• Last updated: April 5, 2011
• Start date: May 2003
• Est. completion date: September 2005

Study information

• Verified date: April 2011
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1452
• Est. completion date: September 2005
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Confirmed acute symptomatic DVT

• Written informed consent

Exclusion Criteria:

• Legal lower age limitations

• Patients with symptomatic pulmonary embolism

• Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT

• Other indication for VKA than DVT

• More than 36 hours before the treatment with therapeutic dosages of low molecular weight heparin or initiation of VKA treatment prior to randomization

• Participation in another pharmacotherapeutic study within the prior 30 days

• Creatinine clearance <10mL/min, severe hepatic disease or bacterial endocarditis

• Life expectancy <3 Months

• Active bleeding or high risk for bleeding

• Uncontrolled hypertension: systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg.

• Pregnancy or childbearing potential without proper contraceptive measures

• Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin (UFH), enoxaparin, or tinzaparin

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• SanOrg34006

• LMW heparin

• Unfractionated heparin

• Vitamin K antagonist (VKA)

Locations

Country	Name	City	State
United States	Lovelace Health Systems	Albuquerque	New Mexico
United States	Inova Alexandria Hospital	Alexandria	Virginia
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Medical College of Georgia	Augusta	Georgia
United States	Boston Medical Center	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	DeKalb Medical Center	Decatur	Georgia
United States	University of Colorado Health Sciences Center	Denver	Colorado
United States	Evanston Northwestern Healthcare	Evanston	Illinois
United States	Pulmonary Associates	Fredericksburg	Virginia
United States	Health System Research Center	Grand Forks	North Dakota
United States	James Muntz	Houston	Texas
United States	Jackson Cardio-Vascular Clinic	Jacksonville	Florida
United States	North Shore University Hospital	Manhasset	New York
United States	Loyola University of Chicago	Maywood	Illinois
United States	MIMA Century Research Associates	Melbourne	Florida
United States	University of Oklahoma HSC	Oklahoma City	Oklahoma
United States	Consultants in Pulmonary Medicine	Olathe	Kansas
United States	St. Joseph Mercy - Oakland Research Center	Pontiac	Michigan
United States	McGuire VAMC	Richmond	Virginia
United States	University of Rochester Medical Center	Rochester	New York
United States	Swedish Medical Center	Seattle	Washington
United States	William Dittman	Spokane	Washington
United States	Scott and White Memorial Hospital & Clinic	Temple	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	symptomatic recurrent pulmonary embolism or deep vein thrombosis within 3 months
Secondary	symptomatic recurrent PE/DVT within 6 months.

External Links

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